Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01836263
Status:
UNKNOWN
Last Update Posted:
2013-04-25
First Post:
2013-04-16
Brief Title:
Prevention and Treatment of Digital Ulcers in Systemic Sclerosis
Sponsor:
marco matucci cerinic
Organization:
University of Florence
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2013-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic sclerosis is an orphan multiorgan disease affecting the connective tissue of the skin and several internal organs
Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic mechanic and inflammatory alone or in combination on the basis of the systemic sclerosis vasculopathy Consequently there are at least three types of DU i those localized at the tips of the fingers and toes mainly resulting from an ischemic process ii those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause and iii those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management
This observational trial is part of the collaborative project DeSScipher one out of five observational trials to decipher the optimal management of systemic sclerosis
Aim of this observational trial is
1 To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACREULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
2 To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACREULAR SSc criteria
Thus the observational trial consist of a prevention arm and a healing arm
Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic mechanic and inflammatory alone or in combination on the basis of the systemic sclerosis vasculopathy Consequently there are at least three types of DU i those localized at the tips of the fingers and toes mainly resulting from an ischemic process ii those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause and iii those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management
This observational trial is part of the collaborative project DeSScipher one out of five observational trials to decipher the optimal management of systemic sclerosis
Aim of this observational trial is
1 To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACREULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
2 To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACREULAR SSc criteria
Thus the observational trial consist of a prevention arm and a healing arm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None